Announced details
Treatment of cutaneous angiosarcoma
Response rate: 13.3%; disease control rate: 86.7%; median progression-free survival: 4.0 months; median overall survival: 20.8 months
Results from a Phase II trial in patients with cutaneous angiosarcoma for whom paclitaxel was ineffective. The number of patients was Not disclosed.
The Minister of Health, Labour and Welfare designated RS5614 as an orphan drug. Discussions with PMDA are under way regarding the conduct of the Phase III trial. The Company is jointly conducting the Phase II trial with Tohoku University Hospital and the other 7 universities and medical institutions in Japan.
The Ministry of Health, Labour and Welfare is the designation authority, PMDA is the agency responsible for reviewing pharmaceutical approvals, and the National Institutes of Biomedical Innovation, Health and Nutrition is the agency that provides grants. Tohoku University Hospital and the other 7 universities and medical institutions in Japan are joint institutions conducting the Phase II trial. Other details, including locations, representatives, capital and year of establishment, are Not disclosed.
Orphan drug designation
Minister of Health, Labour and Welfare
There is no change to the earnings forecast for the fiscal year ending March 2027. The Company will promptly disclose any matters requiring disclosure that arise in the future.
The company does not address Contract Value / Offering price.
Cancer 2022, JCOG1605, timely disclosure dated 10 February 2026
| Item | Details |
|---|---|
| Names of Products / Services Covered | RS5614 (drug for the treatment of cutaneous angiosarcoma) |
| Counterparty | Ministry of Health, Labour and Welfare; Pharmaceuticals and Medical Devices Agency (PMDA); National Institutes of Biomedical Innovation, Health and Nutrition; and 7 universities and medical institutions in Japan, including Tohoku University Hospital |
| Counterparty overview | The Ministry of Health, Labour and Welfare is the designation authority, PMDA is the agency responsible for reviewing pharmaceutical approvals, and the National Institutes of Biomedical Innovation, Health and Nutrition is the agency that provides grants. Tohoku University Hospital and the other 7 universities and medical institutions in Japan are joint institutions conducting the Phase II trial. Other details, including locations, representatives, capital and year of establishment, are Not disclosed. |
| Relationship with the Company | The Minister of Health, Labour and Welfare designated RS5614 as an orphan drug. Discussions with PMDA are under way regarding the conduct of the Phase III trial. The Company is jointly conducting the Phase II trial with Tohoku University Hospital and the other 7 universities and medical institutions in Japan. |
| Applicable area | Treatment of cutaneous angiosarcoma |
| Award/certification name | Orphan drug designation |
| Awarding / certifying body | Minister of Health, Labour and Welfare |
| Quantitative Effects | Response rate: 13.3%; disease control rate: 86.7%; median progression-free survival: 4.0 months; median overall survival: 20.8 months |
| Usage history | Results from a Phase II trial in patients with cutaneous angiosarcoma for whom paclitaxel was ineffective. The number of patients was Not disclosed. |
| Impact on Business Performance | There is no change to the earnings forecast for the fiscal year ending March 2027. The Company will promptly disclose any matters requiring disclosure that arise in the future. |
| Source | Cancer 2022, JCOG1605, timely disclosure dated 10 February 2026 |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Cutaneous angiosarcoma is a serious disease with few patients, a high unmet medical need and limited alternative treatments, and therefore met the criteria for orphan drug designation.